BioSpecifics Reports EU Approval Of XIAPEX To Treat Peyronie's Disease

(RTTNews) - BioSpecifics Technologies Corp. (BSTC) said Swedish Orphan Biovitrum AB (SWTUY.PK) has received approval from the EU Commission to market XIAPEX for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.

BioSpecifics develops first in class collagenase-based products marketed as XIAFLEX in the U.S. and XIAPEX in the EU.

XIAFLEX has been approved in the U.S. for Peyronie's disease since December 2013 and is marketed by BioSpecifics' strategic partner Auxilium Pharmaceuticals, Inc., now a wholly-owned subsidiary of Endo International plc.

"The EU approval of XIAPEX to treat Peyronie's Disease marks an important milestone for patients with this disease, as they now have access to a minimally-invasive treatment. We have been very pleased by the commercial success to date for this indication in the U.S. and are hopeful to see similar success in the EU," said Thomas Wegman, President of BioSpecifics.

Sobi is the Marketing Authorization Holder for XIAPEX in 28 EU member countries, as well as Norway and Iceland, and holds the exclusive rights from Auxilium to commercialize XIAPEX for Dupuytren's contracture and Peyronie's disease indications.

XIAPEX was approved in 2011 in the EU for the treatment of Dupuytren's contracture in adult patients with a palpable cord.

Under the terms of BioSpecifics' agreement with Auxilium, BioSpecifics will receive a certain percentage of milestone payments that Sobi pays to Auxilium as well as royalties from net sales of XIAPEX for Dupuytren's contracture and Peyronie's disease, and payments on costs of goods sold in Sobi territories from Auxilium, which will be a certain percentage of what Auxilium receives from Sobi.